Steerable LAA Closure Device with Expandable Frame
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Solution Overview
Problem
Current medical devices for closing the left atrial appendage (LAA) face challenges in effectively sealing the ostium and aligning with the varying anatomical positions of the LAA, which can lead to incomplete occlusion and increased risk of thrombi formation and stroke.
Innovation Solution
The development of a medical assembly comprising a delivery device with steering wires and an occlusive implant featuring an expandable frame, occlusive covering, and a spherical interface that allows for passive and active steering, enabling precise alignment and expansion within the LAA to ensure complete occlusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a fixed occlusive implant design is used, then manufacturing is simplified, but adaptability to varying LAA anatomical positions is reduced
Solution Approach 1:
The occlusive implant is divided into modular components including a delivery catheter, occlusion device, and steering mechanism. This segmentation allows the implant to be delivered in a compressed state through catheterization while maintaining the ability to expand and adapt to various LAA anatomical configurations upon deployment.
Solution Approach 2:
The occlusive implant incorporates dynamic expansion capabilities, transitioning from a compressed delivery state to an expanded occlusive state. The steering wires and engagement members enable dynamic adjustment of the implant's position and orientation to match varying LAA anatomical positions, resolving the contradiction between manufacturing simplicity and anatomical adaptability.
2Measurement precision
If steering mechanisms are added to the delivery device, then alignment precision with LAA anatomy is improved, but device complexity increases
Solution Approach 1:
Steering wires act as intermediary elements between the operator and the occlusive implant. These wires transmit mechanical forces from the delivery device to the implant, enabling precise steering and positioning. The engagement members serve as intermediaries to temporarily secure the steering wires to the implant during deployment, facilitating controlled manipulation without requiring complex integrated steering mechanisms.
Solution Approach 2:
The occlusive implant incorporates self-aligning features through its expandable structure and steering interface. Once the steering wires are engaged and initial positioning is achieved, the implant's own structural characteristics and expansion mechanism assist in final alignment and secure positioning within the LAA, reducing the need for overly complex external steering控制系统.
3Reliability
If the occlusive implant is made expandable, then occlusion effectiveness is improved, but device complexity increases
Solution Approach 1:
The occlusive implant employs a nested structure where the occlusion device is contained within the expandable frame. This nesting allows the complex expandable structure to be delivered through a simple catheter in a compressed state, then expanded in situ to achieve effective occlusion. The steering interface is similarly nested within the overall implant structure, enabling controlled manipulation without exposing the full complexity during delivery.
Data Source
AI summary
Medical devices as wells as methods for making and using medical devices are disclosed. An example medical device may include a left atrial appendage device. The occlusive medical device includes an expandable frame configured to shift between a first configuration and an expanded configuration and a fabric disposed along at least a portion of the expandable frame. The occlusive medical device may cooperate with a delivery device to permit steering of the occlusive medical device.